Galantamine

Product NDC: 71335-2766
11-digit product format: 713352766
Labeler code: 71335
Product ID: 71335-2766_29de3c5e-581d-4ab9-b0eb-2218eff2e821
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Galantamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA090957
Marketing category: ANDA
Marketing start: 2011-03-29
Substance: GALANTAMINE HYDROBROMIDE
Active strength: 4 mg/1
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090957-001	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29
A090957-002	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29
A090957-003	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090957-001	AB
A090957-002	AB
A090957-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090957-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090957-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090957-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090957-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090957-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090957-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090957-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090957-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090957-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090957-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Galantamine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GALANTAMINE HYDROBROMIDE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MJ4PTD2VVW	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310436	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
261889d3-41c8-4655-98f7-41317778e7a1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f780b87f-43f1-2d63-f0ea-2c214058238e	Product name	2	20160831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71335-2766-1	Galantamine	60 in 1 BOTTLE	TABLET, FILM COATED	60		1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Galantamine	GALANTAMINE	Bryant Ranch Prepack	261889d3-41c8-4655-98f7-41317778e7a1	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090957 application number: ANDA090957 ndc (product): 71335-2766
Galantamine	GALANTAMINE	Bryant Ranch Prepack	694ea1a5-153a-4145-9910-a0a1dc4ddbcc	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090957 application number: ANDA090957
Galantamine	GALANTAMINE	American Health Packaging	e80ec152-3616-4a13-9266-715550a8c398	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090957 application number: ANDA090957
Galantamine	GALANTAMINE	Aurobindo Pharma Limited	4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090957 application number: ANDA090957
Galantamine	GALANTAMINE	Rising Pharma Holdings, Inc.	a0dc1a93-b7b8-4179-8ea7-ceecbe1ef243	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090957 application number: ANDA090957

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MJ4PTD2VVW	GALANTAMINE HYDROBROMIDE	1953-04-4	GALANTAMINE HYDROBROMIDE
0D3Q044KCA	GALANTAMINE	357-70-0	Galantamine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310436	galantamine HBr 4 MG Oral Tablet	PSN	261889d3-41c8-4655-98f7-41317778e7a1	1
310436	galantamine 4 MG Oral Tablet	SCD	261889d3-41c8-4655-98f7-41317778e7a1	1
310436	galantamine 4 MG (as galantamine hydrobromide 5.126 MG) Oral Tablet	SY	261889d3-41c8-4655-98f7-41317778e7a1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2766-1	71335276601	60 TABLET, FILM COATED in 1 BOTTLE (71335-2766-1)	2025-10-03	No	No	Current
71335-2766-2	71335276602	90 TABLET, FILM COATED in 1 BOTTLE (71335-2766-2)	2025-10-03	0		Current